Kornimate/medical-research-clean huggingface dataset:
intuit hip fracture outcome study

Conditions: Unstable Intertrochanteric Hip Fractures

Summary: the primary objective of this study is to characterize patients' course of recovery in the year following the initial surgery for unstable intertrochanteric hip fractures treated with the intertan intramedullary hip screw device. this will be done by collecting patient outcome measures of health related quality of life and functional status including return to normal gait. secondary objectives are to document any adverse events associated with the procedure, and to analyze differences in recovery due to differences in age, gender, co-morbidities, nutrition, residence and ambulation status, and use of mobility aids.


Eligibility criteria:
inclusion criteria: * unilateral unstable intertrochanteric hip fracture without other lower extremity fractures. * community and household ambulators with or without assistive devices. * age 50 years or greater. exclusion criteria: * stable intertrochanteric hip fracture. * bilateral or two or more lower extremity fractures. * non-functional ambulators or non-ambulators. * age less than 50 years.

Keywords: hip fracture intertrochanteric intramedullary
dual mobility in "high risk" patients

Conditions: Dislocation, Hip

Summary: the aim of this study is to compare clinical outcomes of patients considered to be high risk for prosthetic dislocation undergoing primary total hip arthroplasty (tha) with the use of a dual mobility bearing versus a conventional, single bearing design.

this study aims to compare the clinical outcomes of patients considered to be at high risk for prosthetic dislocation undergoing primary total hip arthroplasty (tha) with the use of a dual mobility bearing versus a conventional, single-bearing design. we hypothesize that in primary tha patients considered to be at high risk for prosthetic dislocation, the use of dual-mobility components will be associated with a lower dislocation rate in the first year following the index procedure. we do not anticipate a difference. in other clinical outcome measures or functional outcome scores between the two cohorts. study design: randomized controlled trial with two groups: tha with dual mobility. 44 components vs tha with single-bearing designs

Eligibility criteria:
inclusion criteria: * primary tha for a diagnosis of osteoarthritis or inflammatory arthritis in the setting of a history of prior lumbar or lumbosacral fusion performed at least 6 months prior to their tha. in addition, patients considered high-risk for potential prosthetic dislocation will be included based on the presence of one or more of the following: neuromuscular disorder (e.g. cerebral palsy, parkinson's disease, history of a stroke), dementia or cognitive impairment, substance or alcohol abuse (\>10 drinks per week), acute displaced femoral neck fracture, age \> 75 years, inflammatory arthritis, and increased preoperative range of motion (calculated as described by krenzel et al.: combined flexion, adduction, internal rotation \> 115 degrees). exclusion criteria: * less than 18 years of age * revision tha * spinopelvic fusion that is more recent than 6 months prior to tha * isolated cervical or thoracic fusion * intent to undergo a revision spinopelvic fusion within one year of their index tha * a history of prior infection in the affected hip * a history of prior open surgery on the affected hip (i.e. prior proximal femur fracture or osteotomy) * or a preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture
half-life of plasma phytosterols in preterm infants on parenteral nutrition

Conditions: Liver Diseases

Summary: the purpose of this study is to determine plasma phytosterols half-lives in preterm infants who received intravenous soy oil-based lipid emulsions.

several studies reported the relationship between plasma phytosterol concentrations and parenteral nutrition-associated cholestasis (pnac). information on plasma phytosterols half-lives in very-low-birth-weight (vlbw) preterm infants on lipid parenteral nutrition (pn) are lacking. in a prospective cohort study, plasma phytosterols (campesterol, stigmasterol and sitosterol) of vlbw preterm infants on routine pn will be measured by gas chromatography-mass spectrometry (gc-ms) during pn administration and after only lipid stopping. plasma phytosterols half-lives will be calculated from the monoexponential decay curves. blood samples will be weekly collected from 1st to 7th week of life during routine metabolic tolerance analysis or gas-analysis in order to avoid burden of additional phlebotomy. samples will be collected in ethylenediaminetetraacetic acid-tubes and immediately centrifugated. plasma will be stored in pyrogallol added-tubes at -20°c until analysis. saponification reaction will be done using 5-alpha-cholestane as internal standard.

Eligibility criteria:
inclusion criteria: * 24 weeks \< gestational age \< 32 weeks; * 500 g ≤ birth weight \< 1250 g; * parenteral nutrition with soy oil-based lipid emulsions from the first hours of life; * parental consent. exclusion criteria: * length of parenteral nutrition \> 24 days; * severe malformations; * inborn errors of metabolism; * severe congenital sepsis; * liver dysfunctions.

Keywords: preterm infants phytosterols parenteral nutrition
enteric-coated mycophenolate sodium (ec-mps) with reduced-dose tacrolimus versus ec-mps with standard-dose tacrolimus in stable kidney transplant recipients

Conditions: Kidney Diseases

Summary: this study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to prevent the progression of chronic allograft nephropathy, while maintaining the same efficacy, in maintenance renal transplant recipients.


Eligibility criteria:
inclusion criteria: * primary or secondary kidney transplant * treatment with mycophenolic acid (mmf 1 g/d or ec-mps 720 mg/d) and tacrolimus (trough concentration \[c0\] ≥ 5.5 ng/ml) * creatinine clearance ≥ 30 ml/min and \< 60 ml/min and stable renal function exclusion criteria: * multi-organ recipients or previous transplant with any other organ different from kidney * biopsy proven acute rejection or treated acute rejection within the last 3 months. * prescription of mycophenolate mofetil 1 g/d or mycophenolate sodium 720 mg/d due to adverse event occurrence when higher doses were administered other protocol-defined inclusion/exclusion criteria may apply.

Keywords: dose optimization immune suppressive regimen enteric-coated mycophenolate sodium ec-mps renal transplantation kidney transplant maintenance patients renal transplantation in maintenance
cytochrome p450 2d6 genotype on the clinical effect of carvedilol

Conditions: Healthy

Summary: a clinical study to evaluate the effect of cytochrome p450 2d6 polymorphism on pharmacokinetics/pharmacodynamics after multiple administration of carvedilol

this study has an open-label, one-sequence, multiple drug administration design. the purpose of this study is as follows; to evaluate the change of the result of isoproterenol sensitivity test according to cytochrome p450 2d6 genotype after the multiple administration of carvedilol

Eligibility criteria:
inclusion criteria: * healthy subjects aged 20 - 45 years * a body mass index (bmi) in the range 18.0 kg/m2 (inclusive) - 27.0 kg/m2 (inclusive). * sufficient ability to understand the nature of the study and any hazards of participating in it. provide written informed consent after being fully. informed about the study procedures. exclusion criteria: * presence or history of hypersensitivity or allergic reactions to drugs including investigational product (carvedilol, isoproterenol). * subject judged not eligible for study participation by investigator.

Keywords: carvedilol cyp2d6 isoproterenol sensitivity test
a phase 3, vehicle-controlled efficacy and safety study of idp-123 lotion in the treatment of acne vulgaris (302)

Conditions: Acne Vulgaris

Summary: this is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of idp-123 lotion in comparison with idp-123 vehicle lotion.

this is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of idp-123 lotion and idp-123 vehicle lotion. to be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne.

Eligibility criteria:
inclusion criteria: 1. male or female at least 9 years of age and older; 2. written and verbal informed consent must be obtained. subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit); 3. subject must have a score of 3 (moderate) or 4 (severe) on the evaluator's global severity assessment at the baseline visit; 4. subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50; 5. subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100; 6. subjects with two or fewer facial nodules exclusion criteria: 1. use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study; 2. any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, eczema; 3. any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive; 4. subjects with a facial beard or mustache that could interfere with the study assessments; 5. subjects with more than two (2) facial nodules; 6. evidence or history of cosmetic-related acne
ghrelin, growth hormone and growth factors at high altitude

Conditions: Healthy; Growth Hormone

Summary: regulation of ghrelin, growth hormone and growth factors at high altitude and their change during ascent to high altitude has not been studied in depth yet. the study includes 33 volunteers (12f) investigated at sea level, 4 days after ascent to 3440m and 14 days after ascent to 5400-5900m. the investigators hypothesized that during ascent growth hormone levels would increase to compensate for the higher energy needs at high altitude.


Eligibility criteria:
inclusion criteria: * healthy and good physical fitness

Keywords: mountain medicine ghrelin growth hormone hypoxia physiology of hormonal adaptation to high altitude
efficacy and safety of a multiple-action tear substitute (trimix) in dry eye disease

Conditions: Dry Eye

Summary: the objective of the study is to assess the efficacy and safety of trimix tear substitute in patients with dry eye disease. for this purpose, a randomized, double-blind clinical trial has been designed, using an hyaluronic acid-based tear substitute as a control.


Eligibility criteria:
inclusion criteria: 1. self-reported history ded while working with computer screens ≥ 6 hours per day. 2. ocular surface disease index (osdi) \> 13 points. 3. non-invasive tear film break-up time (nibut) \< 10 s. 4. schirmer test (st) without anesthesia ≥ 5 mm. 5. mgd grade ≤ 1. for mgd, the sirius device (cso, florence, italy) was used, which determines mgd grade based on loss area of meibomian glands (lamg). mgd grade was scored from 0 to 4 (mgd grade 1 = lamg \< 25%; mgd grade 2 = lamg ≥ 25% and \< 50%; mgd grade 3 = lamg ≥ 50% and \< 75%; mgd grade 4 = lamg ≥ 75%). exclusion criteria: 1. abnormal lid anatomy, including active blepharitis, and active lid margin. 2. all corneal disorders that affect diagnostic test, such as active corneal infection and corneal dystrophies. 3. active ocular allergies. 4. vectored thermal pulsation (vtp) intense pulse light (ipl), quantum molecular resonance (qmr), or other procedure to treat ded within the previous 6 months. 5. intraocular surgery or laser ocular surgery within the previous 6 months. 6. use of topical antibiotics and anti-inflammatory treatments, including steroids and non-steroidal anti-inflammatory drugs. 7. systemic autoimmune diseases. 8. contact lens wearers. 9. pregnant or lactating women. 10. patients who did not understand or comprehend the informed consent.
latin america real world study with inspiron drug eluting stent - inspiron latitude

Conditions: Coronary Artery Disease

Summary: prospective, multicenter, single arm registry to monitor post-market clinical outcomes of patients treated with inspiron sirolimus-eluting stent with biodegradable polymer.

prospective, multicenter, single arm registry to assess the safety and performance of inspiron sirolimus-eluting stent with biodegradable polymer for the treatment of "real world" patients.

Eligibility criteria:
inclusion criteria: * all individuals aged over 18 years who signed the informed consent and had lesions in native coronary arteries treated only with inspiron sirolimus-eluting stent. exclusion criteria: * saphenous vein grafts or mammary lesions; * individuals who have been treated within the last 6 months with another stent; * acute myocardial infarction with st segment elevation; * chronic total occlusion

Keywords: coronary disease drug eluting stent inspiron
a study of lw231 to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers and participants with chronic hepatitis b virus infection

Conditions: Chronic Hepatitis B

Summary: to evaluate the tolerability and pharmacokinetics of lw231 tablets in single-center, randomized, double-blind, placebo-controlled multiple-dose, single-dose, multiple-dose phase ia clinical trials in healthy subjects .

the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of lw231 tablets in healthy volunteers and in chronic hepatitis b (chb) patients after single and multiple doses. in addition, the study will evaluate the initial antiviral efficacy of lw231 in chb patients following a multiple dosing regimen.

Eligibility criteria:
inclusion criteria: 1.18-55 years old male or female. 2.body mass index (bmi) between 18 to 28 kg/m2 (inclusive) and body weight equal to or over 45 kg for females and 50kg for males. 3.healthy status will be defined as the absence of evidence of any active or chronic disease following a detailed medical and surgical history, concomitant drug use (including hormonal supplements), a complete physical examination including vital signs, 12-lead ecg, hematology, blood chemistry, serology, and urinalysis. exclusion criteria: 1. any clinically significant abnormalities in laboratory test results at screening. in the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility. 2. participants who have donated over 450 ml of blood or blood products or had significant blood loss within three months prior to screening. 3. heavy smokers (those who smoke greater than or equal to 5 or more cigarettes a day within three months prior to screening).
synergistic effects of natural oils and herbal extracts on cholesterol gallstone dissolution: in vitro comparison with rowachol®

Conditions: Cholesterol Gallstone Dissolution

Summary: objective: this study aims to evaluate the effectiveness of a natural mixture (sesame oil, extra virgin olive oil, psyllium extract, and dandelion extract) in dissolving cholesterol gallstones compared to the standard medication, rowachol®. methods: in laboratory experiments, 70 cholesterol gallstones obtained from 55 patients were divided into seven groups. each group was treated with different combinations of the natural ingredients or rowachol®. the stones were monitored for 144 hours to measure dissolution rate and cholesterol release.


Eligibility criteria:
inclusion criteria: ----------------------------------- diagnosis of cholesterol gallstones requiring surgical removal. gallstones with ≥70% cholesterol composition (confirmed via ftir). gallstone size: 10-13 mm (measured via digital caliper). gallstone weight: 120-150 mg (measured via electronic balance). age range: 40-50 years. bmi: 20-30 kg/m². ------------------------------------------------------------------------------------------------------------------------------ exclusion criteria: ----------------------------------- hepatitis b/c infection. chronic or acute illnesses (e.g., liver cirrhosis, hemolytic anemia). pregnancy or lactation. history of malignancy. participation in other clinical trials within the past 3 months.

Keywords: gallstone dissolution cholesterol gallstones natural oils herbal extracts oleic acid taraxacin rowachol® in vitro study
kt and myofascial release in exc asthma

Conditions: Exercise Induced Asthma

Summary: purpose of this study was to compare between the effects of kinesio tap and myofascial release of respiratory muscles on exercise induced asthma

seventy male athletic subjects with exercise induced asthma, their age ranged from 18-30 years old in this study , with group (a) mean age (21.03+3.6 years), and mean bmi values (27.6+.9 kg/m2) ,and group (b) mean age (21.9+3.8 years),and mean bmi values (27.8+1.3 kg/m2), and group (c) mean age(22+3.1 years), and mean bmi values (27.8+1.3 kg/m2). subjects were assigned randomly into tow study groups and one control group:group(a) 30 subjects were treated by kinesio tap therapy 2sessions per week,ground(b) 30 subjects were treated by myofascial release therapy 3 sessions per week ,group (c) 10 subjects were not recieved treatment.

Eligibility criteria:
inclusion criteria: * seventy male athlete with ages ranging from 18 to 28 years old. their body mass index ranged from "18.5" to "24.9". they have the same level of good aerobic fitness, muscular strength and endurance, and flexibility according to tests results; running or jogging test, push up or sit up test, and sit-and-reach test respectively. exclusion criteria: 1. pulmonary disorders. 2. metabolic disorders (e.g. diabetes mellitus). 3. coronary artery disorders . 4. neurological disorders. 5. recent musculoskeletal injuries. 6. renal disorders. 7. hepatic disorders. 8. skin hypersensitive. 9. smokers

Keywords: pulmonary function test
phase 1 study evaluating ba3182 in patients with advanced adenocarcinoma.

Conditions: Advanced Adenocarcinoma

Summary: the objective of this study is to assess safety and efficacy of ba3182 in advanced adenocarcinoma

this is a multi-center, open-label, phase 1 study designed to evaluate the safety, tolerability, pk, immunogenicity, and antitumor activity of ba3182 in patients with advanced adenocarcinoma.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma * age ≥ 18 years * adequate renal function * adequate liver function * adequate hematological function * have an eastern cooperative oncology group (ecog) performance status of 0 or 1. exclusion criteria: * patients must not have clinically significant cardiac disease. * patients must not have known non-controlled cns metastasis. * patients must not have active autoimmune disease or a documented history of autoimmune disease. * patients must not have a history of ≥ grade 3 allergic reactions to mab therapy as wellas known or suspected allergy or intolerance to any agent given during this study. * patients must not incomplete recovery from the effects of major surgery or significant traumatic injury before the first dose of study treatment. * patients must not have known human immunodeficiency virus (hiv) infection, active hepatitis b and/or hepatitis c. * patients must not be women who are pregnant or breast feeding.

Keywords: advanced metastatic cancer
ezetimibe and atorvastatin vs. atorvastatin in patients age 65 and older at high risk for coronary heart disease (chd)(0653-112)

Conditions: Hypercholesterolemia

Summary: a 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in combination and two higher doses of atorvastatin on lipid lowering.


Eligibility criteria:
inclusion criteria: * patient is age 65 or older * patient is willing to maintain cholesterol lowering diet * patient has hyperlipidemia with ldl level greater than 70 mg/dl or 100 mg/dl depending on their chd risk category exclusion criteria: * a condition which, in the opinion of the investigator, would pose a risk to the patient or interfere with participation in the study * patient is unlikely to be compliant in taking study medication * patient with chronic or unstable medical condition * patient is taking unstable doses of medication * patient drinks more than 2 alcoholic drinks per day * patient has elevations in certain laboratory values (ck, ast, alt)
safety and immunogenicity study of glaxosmithkline (gsk) biologicals' 10-valent pneumococcal conjugate vaccine.

Conditions: Infections, Streptococcal

Summary: three dose primary vaccination of healthy infants between 6 to 16 weeks of age at the time of the first vaccination against streptococcus pneumonia, neisseria meningitidis and haemophilus influenzae type b.


Eligibility criteria:
inclusion criteria: * male or female between, and including, 6-16 weeks (42 to 118 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period. * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3. * previous vaccinations against diseases which are targeted by the vaccines used in the study.

Keywords: streptococcus pneumonia, vaccine